ANDA 040836

HIKMA INTL PHARMS

FDA Drug Application

Application #040836

Application Sponsors

ANDA 040836

HIKMA INTL PHARMS

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	1MG	0	GLYCOPYRROLATE	GLYCOPYRROLATE
002	TABLET;ORAL	2MG	0	GLYCOPYRROLATE	GLYCOPYRROLATE

FDA Submissions

ORIG

1

AP

2009-03-05

CDER Filings

HIKMA INTL PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 40836
            [companyName] => HIKMA INTL PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLYCOPYRROLATE","activeIngredients":"GLYCOPYRROLATE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GLYCOPYRROLATE","activeIngredients":"GLYCOPYRROLATE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GLYCOPYRROLATE","submission":"GLYCOPYRROLATE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GLYCOPYRROLATE","submission":"GLYCOPYRROLATE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)